7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FREE FLEX HEEL HEIGHT ADJUSTOR
FDA 510(k)
FDA Class 1
·Physical Medicine
AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
I.FLEX BY TCS
FDA 510(k)
FDA Class 2
·Dental
NSK TI-MAX X95L
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EGS·April 25, 2014
ASR ACETABULAR CUPS 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 7, 2012
ACS-NT
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS·Product code LNH·August 24, 2010
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012